[Federal Register Volume 59, Number 71 (Wednesday, April 13, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-8819]


[[Page Unknown]]

[Federal Register: April 13, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention
[CDC--410]
RIN 0905-ZA39

 

Announcement of Cooperative Agreement to Case Western Reserve 
University

Summary

    The Centers for Disease Control and Prevention (CDC) announces the 
availability of fiscal year (FY) 1994 funds to continue, on a sole 
source basis, a Human Immunodeficiency Virus (HIV)-Related Tuberculosis 
Demonstration cooperative agreement on applied drug efficacy and 
preventive therapy (ADEPT) with Case Western Reserve University (CWRU). 
Approximately $500,000 will be available in FY 1994 to support this 
project. It is expected the award will begin on August 1, 1994, for a 
12-month budget period within a 5-year project period. Funding 
estimates may vary and are subject to change. Continuation awards 
within the project period will be made on the basis of satisfactory 
progress and availability of funds.
    The purpose of this cooperative agreement is to improve the 
diagnosis, prevention, and treatment of tuberculosis in persons 
infected with HIV through demonstration and applied research. Applied 
research, as used in the context of this announcement, means the 
process of developing and evaluating practical operational approaches 
and solutions to tuberculosis problems.
    The CDC will (1) Provide consultation and technical assistance in 
planning, implementing, and evaluating strategies and protocols, (2) 
Provide up-to-date scientific information on tuberculosis and HIV-
infection and related diseases, (3) Assist in data management, 
analysis, and the evaluation of programmatic activities, and (4) Assist 
in the preparation and publication of results.
    The Public Health Service (PHS) is committed to achieving the 
health promotion and disease prevention objectives of ``Healthy People 
2000,'' a PHS-led national activity to reduce morbidity and mortality 
and improve the quality of life. This announcement is related to the 
priority areas of HIV Infection and Immunization and Infectious 
Diseases. (For ordering a copy of ``Healthy People 2000,'' see the 
Section WHERE TO OBTAIN ADDITIONAL INFORMATION.)

Authority

    This program is authorized under sections 301(a) and 317(k)(2) of 
the Public Health Service Act, [42 U.S.C. 241(a) and 247b(k)(2)], as 
amended.

Smoke-Free Workplace

    The Public Health Service strongly encourages all grant recipients 
to provide a smoke-free workplace and promote the non-use of all 
tobacco products. This is consistent with the PHS mission to protect 
and advance the physical and mental health of the American people.

Eligible Applicant

    Assistance will be provided only to CWRU for this project. No other 
applications are solicited. The program announcement and application 
kit have been sent to CWRU.
    CWRU is the most appropriate and qualified agency to provide the 
services specified under this cooperative agreement because:
    1. In 1991, CWRU was the only applicant funded through the 
competitive announcement #114, ADEPT/HIV-Related Tuberculosis 
Demonstration. The study being conducted is a trial of preventive 
therapy in HIV-infected persons in Uganda; regimens being followed in 
the current study are novel chemotherapy regimens requiring long-term 
follow up of patients to determine the efficacy of these drugs. CWRU 
currently has enrolled more than 600 tuberculin-positive patients in 
the study. During the initial months of recruitment, the investigators 
found a significant number of immunocompromised patients unable to 
respond to skin test antigens (anergic). Since October 1993, these 
patients are being enrolled in the study to assess whether they are at 
even higher risk for the development of tuberculosis and whether 
preventive treatment would be effective. As of November 1993, 11 
anergic patients were participating in the trial. Enrollment into the 
study is continuing; however, there will not be sufficient time in the 
current project period to complete the enrollment of 1200 nonanergic 
and 500 anergic patients and follow these patients for the 2 years 
necessary to collect meaningful data on the efficacy of the preventive 
therapy regimens. Without continuing the project for an additional 5 
years, the data collected to date will be of limited usefulness in 
assessing the efficacy of the regimens evaluated in this study.
    2. The work under this cooperative agreement will be conducted in 
the Republic of Uganda. Uganda has one of the highest prevalences of 
HIV and tuberculous dually-infected persons in the world. The CWRU 
project is able to enroll 20 nonanergic and 5 anergic patients each 
week; no other known sites have access to sufficient patients to enroll 
at this rate. This rate of enrollment is necessary to ensure that 
sufficient numbers of patients are enrolled to provide statistically-
valid results within a relatively short period of time. The CWRU 
research team also has established relations with Ugandan institutions 
that should ensure the success of a high-quality trial. Results on the 
efficacy of preventive therapy regimens in HIV-infected persons are 
needed to aid in the elimination of tuberculosis in the United States, 
as outlined in ``A Strategic Plan for the Elimination of Tuberculosis 
in the United States.''
    3. CWRU possesses proven scientific and managerial competence in 
treating TB patients and in conducting clinical research trials. Many 
of the patients in the current cohort have been followed for as long as 
a year with very few patients lost to follow up. CWRU has been 
successful in other CDC-funded clinical trials involving the long-term 
follow-up (2 years or more) of HIV-infected persons.
    4. To date, CDC has provided over $1,000,000 to establish this 
cohort. Use of this cohort will be less expensive and provide more 
timely results than to begin enrollment of another cohort at a 
different site. Additionally, no other known site can provide 
enrollment at the rate necessary to adequately assess the treatment 
regimens.
    5. The current spread of TB demands new methods for combating this 
disease. The results of this study will add significantly to the body 
of information on the efficacy of specific regimens in preventing 
tuberculosis in HIV-infected persons. The rifampin-containing regimens 
may provide options for preventing tuberculosis in HIV-infected persons 
exposed to INH-resistant organisms.

Executive Order 12372 Review

    The application is not subject to review as governed by Executive 
Order 12372, Intergovernmental Review of Federal Programs.

Public Health System Reporting Requirements

    This program is not subject to the Public Health System Reporting 
Requirement.

Catalog of Federal Domestic Assistance Number

    The Catalog of Federal Domestic Assistance Number is 93.947, 
Tuberculosis Demonstration, Research, Public and Professional 
Education; and 93.941, Human Immunodeficiency Virus (HIV) 
Demonstration, Research, Public and Professional Education.

Other Requirements

Human Subjects

    The applicant must comply with the Department of Health and Human 
Services regulations (45 CFR part 46) regarding the protection of human 
subjects. Assurance must be provided to demonstrate that the project 
will be subject to initial and continuing review by an appropriate 
institutional review committee. The applicant will be responsible for 
providing assurance in accordance with the appropriate guidelines and 
form provided in the application kit.

Confidentiality

    Applicant must have in place systems to insure the confidentiality 
of all patient records.

Pre- and Post-test Counseling and Partner Notification

    Recipient is required to provide HIV antibody testing to determine 
a person's HIV infection status; therefore, they must comply with local 
laws and regulations and CDC guidelines regarding pre- and post-test 
counseling and partner notification of HIV-seropositive patients, a 
copy of which will be included in the application kit. Recipient must 
also comply with local requirements relating to specific reportable 
diseases or conditions. Recipient must provide referrals for HIV 
diagnosis and treatment.

Where to Obtain Additional Information

    If you are interested in obtaining additional information regarding 
this project, please refer to Announcement 410 and contact Manuel 
Lambrinos, Grants Management Specialist, Grants Management Branch, 
Procurement and Grants Office, Centers for Disease Control and 
Prevention (CDC), 255 East Paces Ferry Road, NE., Room 300, Mailstop E-
16, Atlanta, GA 30305, telephone (404) 842-6777.
    A copy of ``Healthy People 2000'' (Full Report; Stock No. 017-001-
00474-0) or ``Healthy People 2000'' (Summary Report; Stock No. 017-001-
00473-1) referenced in the SUMMARY may be obtained through the 
Superintendent of Documents, Government Printing Office, Washington, DC 
20402-9325, telephone (202) 783-3238.

    Dated: April 7, 1994.
Robert L. Foster,
Acting Associate Director for Management and Operations, Centers for 
Disease Control and Prevention (CDC).
[FR Doc. 94-8819 Filed 4-12-94; 8:45 am]
BILLING CODE 4163-18-P